Mouth Handicap in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

Mouth Handicap in Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273386
• Other study ID #: ISTANBULC1
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: March 20, 2022

Study information

• Verified date: April 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.

Description:

Systemic Sclerosis is an autoimmune connective tissue disease with fibrosis. Although its etiology and pathogenesis have not been clearly defined, it has a chronic course. Systemic sclerosis is estimated to affect approximately 300,000 people in the United States. Most commonly, it affects adults and women. Narrowing of the mouth opening and mouth pain are the two most important causes reported by adults with systemic sclerosis. In patients with systemic sclerosis, orofacial findings such as microstomy or reduced mouth opening are frequently seen. Microstomy is defined as the distance between the incisors is less than 40 millimeters. In severe microstomy, this distance is less than 30 millimeters. It is approximately 33 millimeters in adults with systemic sclerosis. Microstomy in systemic sclerosis mainly results from submucosal collagen deposits that contribute to fibrosis in the perioral tissue. Microstomy is seen in 43% to 80% of adults with systemic sclerosis. When the current literature is examined, Bongi et al. evaluated the effectiveness of face-specific programs, which are applied together with general rehabilitation programs in patients with systemic sclerosis; they demonstrated that these techniques improve disability, health-related quality of life (HRQoL), and facial functionality. In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 20, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• To be diagnosed with systemic sclerosis
• Stability of medical treatments
• Turkish literacy

Exclusion Criteria:

• The patient has a history of neurological disease or trauma that may affect his symptoms
• Oral treatment for the last 6 months
• Being in active phase of the disease
• Skin infection and presence of open wound
• Having used dental orthosis in the last month
• Disorder of cognition or cooperation

Related Conditions & MeSH terms

• Mouth Diseases
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Evaluation
The study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	I?stanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Maddali Bongi S, Del Rosso A, Miniati I, Galluccio F, Landi G, Tai G, Matucci-Cerinic M. The Italian version of the Mouth Handicap in Systemic Sclerosis scale (MHISS) is valid, reliable and useful in assessing oral health-related quality of life (OHRQoL) in systemic sclerosis (SSc) patients. Rheumatol Int. 2012 Sep;32(9):2785-90. doi: 10.1007/s00296-011-2049-x. Epub 2011 Aug 17. — View Citation

Mouthon L, Rannou F, Bérezné A, Pagnoux C, Arène JP, Foïs E, Cabane J, Guillevin L, Revel M, Fermanian J, Poiraudeau S. Development and validation of a scale for mouth handicap in systemic sclerosis: the Mouth Handicap in Systemic Sclerosis scale. Ann Rheum Dis. 2007 Dec;66(12):1651-5. Epub 2007 May 14. — View Citation

Naylor WP, Douglass CW, Mix E. The nonsurgical treatment of microstomia in scleroderma: a pilot study. Oral Surg Oral Med Oral Pathol. 1984 May;57(5):508-11. — View Citation

Scardina GA, Messina P. Systemic sclerosis: description and diagnostic role of the oral phenomena. Gen Dent. 2004 Jan-Feb;52(1):42-7. — View Citation

Schouffoer AA, Strijbos E, Schuerwegh AJ, Mouthon L, Vliet Vlieland TP. Translation, cross-cultural adaptation, and validation of the Mouth Handicap in Systemic Sclerosis questionnaire (MHISS) into the Dutch language. Clin Rheumatol. 2013 Nov;32(11):1649-55. doi: 10.1007/s10067-013-2321-4. Epub 2013 Jul 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS)	Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS): This is a self-reported scale specific to the disease that questions oral involvement in systemic sclerosis. It consists of 12 items that evaluate features such as mouth opening, chewing, tooth structure, lip structure, dry mouth, fluent speech, and facial appearance. It is answered according to the five-point Likert system: 0: Never, 1: Rarely, 2: Sometimes, 3: Frequently, 4: Always. The higher the total score, the higher the severity of the problem.	at first day and second week change
Secondary	Scleroderma Health Assessment Questionnaire (SHAQ)	Scleroderma Health Assessment Questionnaire (SHAQ): The SHAQ includes 5 visual analog scale questions that question Raynaud's phenomenon, digital ulcer, gastrointestinal and pulmonary respiratory symptoms, as well as the patient's overall disease severity. In addition, there are 20 questions (HAQ) evaluating the functional competence level of the patient. Each question is between 0-3 points (0: no difficulty and 3: can not). In the scoring of the sections, the highest score among the items constituting that section is accepted as the section score. The score of each category is summed and divided by the total number of categories, 8 to obtain the SHAQ disability score.	at first day
Secondary	Oral Health Impact Profile (OHIP-14)	It is a self-report scale that questions the proportion of individuals experiencing oral health problems. Likert response system; 0: None, 1: Rarely, 2: Sometimes, 3: Often, 4: Very often. The evaluation shows the total score of the participants' responses to each item, while OHIP-14 A (additive) shows the number of responses that a participant gave as 2 (sometimes) and 3 (often) in 14 items. The increase in the total score indicates that the severity of the problem increases and quality of life decreases.	at first day
Secondary	Eating Assessment Tool (EAT-10)	It is a single factor scale used to evaluate the severity and change of dysphagia symptoms. It consists of ten items. Each item is scored from 0 to 4. The total score ranges from 0 to 40. The scale is considered to be abnormal 3 points or more.	at first day